Specialty: Ear, nose and throat, Primary sub-specialty: Ear, nose and throat
Conditions
Interventions
This study consists of two phases:
Phase One (optimisation group):
Participants who are undergoing planned (elective) operations will be asked permission for a biopsy to be taken from the nose and th
Sponsors
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Phase 1: 1. Have capacity to give informed consent 2. Aged 18-50 years (ages chosen to minimise discrepancy in the immune response and to minimise the risk of pneumococcal disease) 3. Speak fluent English (to ensure a comprehensive understanding of the research project and their proposed involvement, in order to minimise any communication issues to maximize participant safety) Phase 2: 1. Have capacity to give informed consent 2. Aged 18-50 years (ages chosen to minimise discrepancy in the immune response and to minimise the risk of pneumococcal disease) 3. Speak fluent English (to ensure a comprehensive understanding of the research project and their proposed involvement, in order to minimise any communication issues to maximize participant safety) 4. Consented for elective nasal septum and or turbinate surgery
Exclusion criteria
Exclusion criteria: Stage One-Optimization group 1. Chronic rhinosinusitis (CRS) with or without nasal polypoidal disease 2. Use of oral of nasal steroid spray up to the day of surgery 3. Currently involved in another study unless observational or in follow-up phase (non-interventional) Stage Two Group One 1. Currently involved in another study unless observational or in follow-up phase (non-interventional) 2. Close contact with at risk individuals (children under 5 years, immunosuppressed adults, elderly, chronic ill health) – to minimise risk of pneumococcal transmission 3. Current regular smoker (smokes daily) or previous regular smoker that has stopped smoking less than 12 months ago (< 10 years). 4. Asthma or respiratory disease – to minimise risk of pneumococcal disease 5. Current acute or chronic rhinosinusitis with or without nasal polypoidal disease 6. Pregnant - to minimise the risk of pneumococcal disease 7. Allergic to penicillin or amoxicillin 8. Allergic to local anaesthetic 9. On medication that may affect the immune system in any way e.g. steroids 10. Been involved in a clinical trial involving EHPC over the last 3 years 11. Current acute severe febrile illness 12. Taking long term antibiotics 13. On oral anti-platelets or warfarin therapy Group Two 1. Currently involved in another study unless observational or in follow-up phase (non-interventional) 2. Close contact with at risk individuals (children under 5 years, immunosuppressed adults, elderly, chronic ill health) – to minimise risk of pneumococcal transmission 3. Current regular smoker (smokes daily) or previous regular smoker that has stopped smoking less than 12 months ago (< 10 years). 4. Asthma or respiratory disease – to minimise risk of pneumococcal disease 5. Current acute or chronic rhinosinusitis with or without nasal polypoidal disease 6. Pregnant - to minimise the risk of pneumococcal disease 7. Allergic to penicillin or amoxicillin 8. On medication that may affect the immune system in any way e.g. steroids, 9. Been involved in a clinical trial involving EHPC over the last 3 years 10. Current acute severe febrile illness 11. Taking long term antibiotics 12. Previous tonsillectomy *Participants that have been started on nasal steroid spray to relive the nasal blockage symptoms will be advised to stop **Participants in Group 2 on oral anti-platelets therapy of warfarin are advised to stop the medication up to seven days prior to their elective nasal surgery and additional nasal and tonsillar biopsy to minimise the risk of bleeding as per the pre-operative assessment clinic advise.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of cell populations are measured using the nasal/tonsil biopsy at day 10 and 23 post inoculation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of cell populations are measured between carriage positive and carriage negative subjects at day 10 and day 23. Association between early induction of specific genes with percentages of cell populations are measured in carriage -positive subjects. | — |
Countries
England, United Kingdom
Contacts
Public ContactLepa Lazarova
Outcome results
None listed